MAUDE Adverse Event Report: NEWDEAL SAS DEEVICE FOR NAIL FIXATION; PANTA NAIL

Catalog Number 519110ND

Device Problem Difficult to Insert (1316)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/10/2014

Event Type  malfunction  

Event Description

This is the first of two reports concerning the panta device used in the same surgery on the same pt.This report concerns the device for nail fixation 51911nd.It was reported the two parts 519110 (panta support) and 519130 (panta compression instrument) are inserted with difficulties; difficulties to have both straight.The surgeon used paraffin jelly to insert it.There was no pt injury reported.Surgery time was increased by 5 minutes.

Manufacturer Narrative

To date the device involved in the reported incident has not been received for evaluation.An investigation has been initiated based on the reported information.

• Brand Name: DEEVICE FOR NAIL FIXATION
• Type of Device: PANTA NAIL
• Manufacturer (Section D): NEWDEAL SAS; saint priest 6980 0; FR 69800
• Manufacturer Contact: caren finkelstein ; 315 enterprise drive; plainsboro, NJ 08536 ; 6099362341
• MDR Report Key: 4152347
• MDR Text Key: 21526157
• Report Number: 9615741-2014-00048
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K091788
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 519110ND
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/10/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1